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Drugs. 2019 Jan;79(1):85-91. doi: 10.1007/s40265-018-1036-x.
Revefenacin (YUPELRI™) inhalation solution, a long-acting muscarinic antagonist (i.e. an anticholinergic) developed by Theravance Biopharma and Mylan, is the first and currently the only once-daily, nebulized bronchodilator to be approved in the USA for the treatment of chronic obstructive pulmonary disease (COPD). In November 2018, based on results of three phase III trials, the US Food and Drug Administration granted market authorization to revefenacin for the maintenance treatment of patients with COPD. This article summarizes the milestones in the development of revefenacin leading to this first global approval.
瑞福纳嗪（YUPELRI™）吸入溶液，一种由 Theravance Biopharma 和迈兰开发的长效毒蕈碱拮抗剂（即抗胆碱能药），是美国批准的首个也是目前唯一的每日一次雾化支气管扩张剂，用于治疗慢性阻塞性肺疾病（COPD）。2018 年 11 月，基于三项 III 期试验的结果，美国食品和药物管理局批准瑞福纳嗪用于 COPD 患者的维持治疗。本文总结了瑞福纳嗪开发过程中的重要里程碑，最终使其获得了这一全球首次批准。
